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Open Access Research article

Severe hypoglycemia symptoms, antecedent behaviors, immediate consequences and association with glycemia medication usage: Secondary analysis of the ACCORD clinical trial data

Denise E Bonds1*, Michael E Miller2, Jim Dudl3, Mark Feinglos4, Faramarz Ismail-Beigi5, Saul Malozowski6, Elizabeth Seaquist7, Debra L Simmons8 and Ajay Sood9

Author Affiliations

1 National Heart Lung and Blood Institute, National Institute of Health, Bethesda, MD, USA

2 Department of Biostatistical Sciences, Division of Public Health Sciences, Wake Forest University School of Medicine, Winston-Salem, NC, USA

3 Care Management Institute, Kaiser Permanente, Oakland, CA, USA

4 Department of Medicine, Duke University Medical Center, Durham, NC, USA

5 Department of Medicine, Case Western Reserve University, Cleveland, OH, USA

6 Division of Diabetes, Endocrinology and Metabolic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD, USA

7 Division of Endocrinology and Diabetes, Department of Medicine, University of Minnesota Medical School, Minneapolis, MN, USA

8 Division of Medicine, Endocrinology, Central Arkansas Veterans Healthcare System and University of Arkansas for Medical Sciences, Little Rock, AR, USA

9 Division of Endocrinology, Department of Medicine, Case Western Reserve University, Cleveland, OH, USA

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BMC Endocrine Disorders 2012, 12:5  doi:10.1186/1472-6823-12-5

Published: 30 May 2012

Abstract

Background

Hypoglycemia is a common complication of diabetes treatment. This paper describes symptoms, predecessors, consequences and medications associated with the first episode of severe hypoglycemia among ACCORD participants with type 2 diabetes, and compares these between intensive (Int: goal A1C <6.0%) and standard (Std, goal A1C 7–7.9%) glycemia intervention groups.

Methods

Information about symptoms, antecedents, and consequences was collected at the time participants reported an episode of severe hypoglycemia. Data on medications prescribed during the clinical trial was used to determine the association of particular diabetes drug classes and severe hypoglycemia.

Results

The most frequently reported symptoms in both glycemia group were weakness/fatigue (Int 29%; Std 30%) and sweating (Int 26%; Std 27%), followed by confusion/disorientation (Int 22%; Std 29%) and shakiness (Int 21%; Std 19%). Approximately half of all events were preceded by a variation in food intake (Int 48%; Std 58%). The most common consequences were confusion (Int 37%; Std 34%), loss of consciousness (Int 25%; Std 25%), and hospitalization (Int 18%; Std 24%). The highest rates of hypoglycemia were found among those participants treated with insulin only (Int 6.09/100 person yrs; Std 2.64/100 person yrs) while the lowest were among those prescribed oral agents only (Int 1.93/100 person yrs; Std 0.20/100 person yrs).

Conclusions

Severe hypoglycemia episodes were frequently preceded by a change in food intake, making many episodes potentially preventable. Symptoms of confusion/disorientation and loss of consciousness were frequently seen. The highest rates of hypoglycemia were seen with prescription of insulin, either alone or in combination with other medications.

Clinical Trial Registration

Number: NCT00000620

Keywords:
Hypoglycemia; Type 2 diabetes